Chest compression device with electro-stimulation

ABSTRACT

A device for performing chest compressions for CPR in coordination with applying electro-stimulus for additional resuscitative actions such as electro-ventilation, electro-counterpulsion, and defibrillation. The device includes a chest compression mechanism, electrodes and power supply for electro-stimulus, and a control system for applying electro-stimulus in coordination with the action of the chest compression mechanism.

This application is a continuation of U.S. application Ser. No.10/648,007, filed Aug. 25, 2003, now U.S. Pat. No. 7,011,637 which is acontinuation of U.S. application Ser. No. 09/829,859, filed Apr. 9,2001, now abandoned, which is a continuation of U.S. application Ser.No. 09/100,840, filed Jun. 19, 1998, now U.S. Pat. No. 6,213,960.

FIELD OF THE INVENTIONS

This invention relates to the resuscitation of cardiac arrest victims.

BACKGROUND OF THE INVENTIONS

Cardiopulmonary resuscitation (CPR) is a well known and valuable methodof first aid. CPR is used to resuscitate people who have suffered fromcardiac arrest after heart attack, electric shock, chest injury and manyother causes. During cardiac arrest, the heart stops pumping blood, anda person suffering cardiac arrest will soon suffer brain damage fromlack of blood supply to the brain. Thus, CPR requires repetitive chestcompression to squeeze the heart and the thoracic cavity to pump bloodthrough the body. Very often, the victim is not breathing, and mouth tomouth artificial respiration or a bag valve mask is used to supply airto the lungs while the chest compression pumps blood through the body.The methods of providing oxygenated airflow to the lungs are referred toas ventilation.

It has been widely noted that CPR and chest compression can save cardiacarrest victims, especially when applied immediately after cardiacarrest. Chest compression requires that the person providing chestcompression repetitively push down on the sternum of the victim at80-100 compressions per minute. CPR and closed chest compression can beused anywhere, wherever the cardiac arrest victim is stricken. In thefield, away from the hospital, CPR may be accomplished by ill-trainedby-standers or highly trained paramedics and ambulance personnel.

When a first aid provider performs chest compression well, blood flow inthe body is typically about 25-30% of normal blood flow. This is enoughblood flow to prevent brain damage. However, when chest compression isrequired for long periods of time, it is difficult if not impossible tomaintain adequate compression of the heart and rib cage. Evenexperienced paramedics cannot maintain adequate chest compression formore than a few minutes. Hightower,. et al., Decay In Quality Of ChestCompressions Over Time, 26 Ann. Emerg. Med. 300 (September 1995). Thus,long periods of CPR, when required, are not often successful atsustaining or reviving the victim. At the same time, it appears that, ifchest compression could be adequately maintained, cardiac arrest victimscould be sustained for extended periods of time. Occasional reports ofextended CPR efforts (45-90 minutes) have been reported, with thevictims eventually being saved by coronary bypass surgery. See Tovar, etal., Successful Myocardial Revascularization and Neurologic Recovery, 22Texas Heart J. 271 (1995).

In efforts to provide better blood flow and increase the effectivenessof bystander resuscitation efforts, modifications of the basic CPRprocedure have been proposed and used. Various devices and methodsdescribed below are proposed for use in a main operative activity ofCPR, namely repetitive compression of the thoracic cavity. The deviceshown in Barkalow, Cardiopulmonary resuscitator Massager Pad, U.S. Pat.No. 4,570,615 (Feb. 18, 1986), the commercially available Thumperdevice, and other such devices, provide continuous automatic closedchest compression. Barkalow and others provide a piston which is placedover the chest cavity and supported by an arrangement of beams. Thepiston is placed over the sternum of a patient and set to repeatedlypush downward on the chest under pneumatic power. The victim must firstbe installed into the device, and the height and stroke length of thepiston must be adjusted for the patient before use, leading to delay inchest compression. Other analogous devices provide for hand operatedpiston action on the sternum. Everette, External Cardiac CompressionDevice, U.S. Pat. No. 5,257,619 (Nov. 2, 1993), for example, provides asimple chest pad mounted on a pivoting arm supported over a patient,which can be used to compress the chest by pushing down in the pivotingarm. These devices are not clinically more successful than manual chestcompression. See Taylor, et al., External Cardiac Compression, ARandomized Comparison of Mechanical and Manual Techniques, 240 JAMA 644(August 1978). Other devices for mechanical compression of the chestprovide a compressing piston which is secured in place over the sternumvia vests or straps around the chest. Woudenberg, CardiopulmonaryResuscitator, U.S. Pat. No. 4,664,098 (May 12, 1987) shows such a devicewhich is powered with an air cylinder. Waide, et al., External CardiacMassage Device, U.S. Pat. No. 5,399,148 (Mar. 21, 1995) shows anothersuch device which is manually operated.

Lach, et al., Resuscitation Method and Apparatus, U.S. Pat. No.4,770,164 (Sep. 13, 1988) proposed compression of the chest with wideband and chocks on either side of the back, applying a side-to-sideclasping action on the chest to compress the chest. Kelly, et al., ChestCompression Apparatus for Cardiac Arrest, U.S. Pat. Nos. 5,738,637(5,738,673) proposed compression of the chest using a wide bandrepeatedly tightened about the chest with a lever assembly placed on thepatients sternum and operated manually. The Kelly devices comprises abase which is placed over a central region of the chest, a belt which iswrapped around the patients chest and fastened at its opposite ends tothe base, and a force converter connected to the base and the belt, anda manual actuator, so that the force converter converts the downwardforce on the manual actuators into chest compressing resultants directedtoward the chest and directed tangentially to the chest. Although Kellyillustrates installation of defibrillation electrodes on the wide band,he does not suggest integrating use of the electrodes with use of thecompression belt in any manner.

In another variation of such devices, a vest or belt designed forplacement around the chest is provided with pneumatic bladders which arefilled to exert compressive forces on the chest. Scarberry, Apparatusfor Application of Pressure to a Human Body, U.S. Pat. No. 5,222,478(Jun. 29, 1993) and Halperin, Cardiopulmonary Resuscitation and AssistedCirculation System, U.S. Pat. No. 4,928,674 (May 29, 1990) show examplesof such devices. Halperin, for example, uses a vest fitted with airbladders that are repeatedly inflated to compress the chest. Thebladders are deflated by application of a vacuum. Cyclic inflation anddeflation of the vest is accomplished with a complicated arrangement oftwo-way and three-way valves, connected to the bladders within the vestwith large bore hoses.

Our own CPR devices use a compression belt around the chest of thepatient which is repetitively tightened and relaxed through the actionof a belt tightening spool powered by an electric motor. The motor iscontrolled by control system which times the compression cycles, limitsthe torque applied by the system (thereby limiting the power of thecompression applied to the victim), provides for adjustment of thetorque limit based on biological feedback from the patient, provides forrespiration pauses, and controls the compression pattern through anassembly of clutches and/or brakes connecting the motor to the beltspool. Our devices have achieved high levels of blood flow in animalstudies.

Abdominal binding is a technique used to enhance the effectiveness ofthe CPR chest compression. Abdominal binding is achieved by binding thestomach during chest compression to limit the waste of compressive forcewhich is lost to deformation of the abdominal cavity caused by thecompression of the chest. It also inhibits flow of blood into the lowerextremities (and promotes bloodflow to the brain). Alferness,Manually-Actuable CPR apparatus, U.S. Pat. No. 4,349,015 (Sep. 14, 1982)provides for abdominal restraint during the compression cycle with abladder that is filled during compression. Counterpulsion is a method inwhich slight pressure is applied to the abdomen in between each chestcompression. A manual device for counterpulsion is shown in Shock, etal., Active Compression/Decompression Device for CardiopulmonaryResuscitation, U.S. Pat. No. 5,630,789 (May 20, 1997). This device islike a seesaw mounted over the chest with a contact cup on each end ofthe seesaw. One end of the seesaw is mounted over the chest, and theother end is mounted over the abdomen, and the device is operated byrocking back and forth, alternately applying downward force on each end.

Electroventilation is the process of ventilating a patient. byelectrically stimulating the nerves that control the muscles used forrespiration. It is proposed for use in patients that have been paralyzedsuch that the normal motor impulses transmitted to the diaphragm are nottransmitted. Geddes, Demand Electroventilator, U.S. Pat. No. 4,827,935(May 9, 1989) illustrates the operation of an electroventilator. Heillustrates placement of two electrodes on the chest (one on eitherside), and application of electrical stimulus through the electrodes tostimulate the nerves responsible for triggering the muscles used inrespiration. Geddes system provided for smooth inspiration, which was animprovement over the sharp gasping action caused by earlierelectroventilation systems. The nerves identified by Geddes are thephrenic nerve, which controls the diaphragm, and the intercostal nerveswhich control the intercostal muscles (muscles between the ribs).

SUMMARY

The devices and methods described below combine mechanisms forcompressing the chest with electrical devices for conducting otherbeneficial components of cardiopulmonary resuscitation and the ACLSprotocol. A set of electrodes is provided on the neck and/or chest ofthe patient for electrically stimulating the diaphragm to provide aninhalation, thereby ventilating the patient, and a control systemprovides for coordination of the ventilating stimulus with thecompression system so that ventilation is initiated during ventilationpauses in the compression pattern (these compression pauses wouldnormally be used for mouth-to-mouth or bag ventilation). A set ofelectrodes is provided for installation over the patient's abdomen, tocause contraction of the abdominal muscles, and a control systemprovides for coordination of the abdominal muscle stimulation and thechest compression mechanism in order to effect abdominal binding orcounterpulsion. A set of electrodes is provided for defibrillating thepatient, and a control system is provided for coordinating theinitiating the defibrillation shock in sync with the chest compressionmechanism. The defibrillation electrodes may be used for pacing theheart. Additional electrodes may be supplied for control of the glotticopening. An overall control system is provided for coordinating theaction of the chest compression device with the operation of variouselectrical stimulus devices to enhance the effectiveness of theresuscitation regimen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is diagram of a typical chest compression device.

FIG. 2 is diagram of a typical patient illustrating the electrodeplacement.

FIG. 3 is a block diagram of the motor control system for use for basicCPR chest compression.

FIG. 4 is a block diagram of the motor control system for use inelectro-ventilation during respiration pauses of the compression system,for use in electro-counterpulsion during operation of the compressionsystem, and for use in the synchronized cardioverting shock system.

DETAILED DESCRIPTION OF THE INVENTIONS

FIG. 1 shows the system mounted on a patient 1 and ready for use. Thechest compression subsystem 2 comprises the motor box 3, the beltcartridge 4, and the compression belt 5 with left and right portions 5Land 5R. The belt is fastened around the patient with fasteners 6, whichmay be buckles, Velcro® hook and loop fasteners or other fasteners withsensors to sense when the belt is fastened. Ventilation electrodes 7Land 7R are mounted on the belts in the area of the lower chest, over thediaphragm, placed bilaterally. Bipolar electrodes 8L and 8R (orelectrode pairs) may also be placed on the neck, bilaterally, tostimulate the phrenic nerve which courses downwardly through the neck.Defibrillation electrodes 9R and 9L are placed in the right sternumparasaggital location 10 and left rib medial location 11, and they mayalso be located below the patient, on the spine between the shoulderblades, and on the center of the chest, respectively. These electrodesare also used for establishing the electrical contact needed for EKGsensing. Counterpulsion electrodes 12 i and 12 s are placed on the skinover the abdominal or rectus muscles, with a line of positive electrodesplaced in the superior position and a line of ground electrodes placedin the inferior position. Glottic control electrodes are disposed onelectrode patch 13 placed on the neck along the tracheo-esophagealgroove.

FIG. 2 illustrates the nerves of the human body upon which theelectro-stimulation system may act. The phrenic nerves 14L and 14R arebelieved to be used by the body to control the diaphragm 15. The phrenicnerves course from the neck 16, superficially over the scalene muscles,and deep within the chest around the heart to the diaphragm. The phrenicnerves divide into the phrenicoabdominal branches 17. The phrenic nervescomprise both efferent and afferent nerves which run together alongtheir common course. The phrenic nerves and the diaphragm are principalcomponents of breathing. Other nerves and muscles which are used inbreathing are the intercostal nerves, located between the ribs 18 andcontrolling the external intercostal muscles, and the internalintercostal muscles. The abdominal muscles 19, controlled by intercostalnerves, are used in active breathing. The electrodes 7L and 7R, 8L and8R, 9L and 9R, 12 i and 12 s, and 13 are illustrated in the appropriatepositions as viewed from the front of the patient.

The airway is controlled by the glottic opening (including the vocalcords) which is controlled by the recurrent laryngeal nerve. Theoperation of the glottis is not typically impaired in cardiac arrestpatients. However, its operation can be influenced by electricalstimulation of the recurrent laryngeal nerves, and closure during thecompression period of the CPR device enhances intrathoracic pressure.The recurrent laryngeal nerve may be stimulated with electricalstimulation delivered most conveniently through an electrode mounted onthe skin of the neck, along the tracheo-esophageal groove. It may alsobe activated from inside the throat of the patient by applyingelectrical stimulation directly to the vocal cords, or through thetracheal wall or the esophageal wall (with electrodes mounted on an ETtube, which is routinely inserted by emergency medical technicians).Stimulation of the RLN will open or close the glottic opening dependingon the frequency of the applied electrical stimulus. For transcutaneousstimulation, stimulation at frequencies below 30 Hertz cause the vocalcord to open, while stimulation at frequencies from 40-100 Hertz willcause the vocal cords to close. Stimulation with pulses ranging up to 20milli-amps and pulses of 0.5 msec to 2 msec duration should be effectiveto stimulate closure of the glottic opening.

There are two electrical mechanisms that can be used to activate amuscle within the body, and the systems described below can allow forboth. First, the motor nerve (such as the phrenic nerve) is used by thebody to transmit a nervous system impulse to activating nerves whichdirectly innervate the muscles. The motor nerves may be stimulated by anelectrical pulse to cause the motor nerve to stimulate the activatingnerves within the muscle to be contracted. Second, the activating nervesthat directly innervate the muscles may be locally stimulated to causemuscle contraction. The diaphragm, the intercostal muscles, and theabdominal muscles may be stimulated with both electrical mechanisms.

The CPR device illustrated in FIG. 1 stimulates the motor nerve and theactivating nerves, either singly or together, to cause contraction ofthe diaphragm, the intercostal muscles, and the abdominal muscles. Thediaphragm and the intercostal muscles are stimulated in coordinationwith the compression mechanism to cause those muscles to cause aninhalation. The abdominal muscles are stimulated in coordination withthe compression mechanism to make those muscles contract. Thecontraction of the abdominal muscles results in a binding of the abdomenthat, when syncopated with chest compressions provides an electricallyinduced version of counterpulsion which increases the effectiveness ofthe chest compression mechanism in creating blood flow within a patient.

The manner in which electrical stimulation may be applied may varyconsiderably and yet still provide effective activation of the musclegroups involved. The electrical stimulation is preferably applied inrepeated bursts comprising a number of pulses. The pulses arecharacterized by their pulse width and pulse amplitude (current orvoltage). The pulse bursts, or pulse trains, may be characterized by thepulse train width and the number of pulse bursts per second. In eachinstance, the pulses employed may be monophasic, biphasic, orpolyphasic, according to medical indications at the time of use. Thepulses may be DC pulses or AC pulses of varying frequency.

For stimulation of the respiratory muscles, we prefer an electricalpulse pattern which causes a smooth inhalation. The respiratorystimulation is provided through the electrodes 8L and 8R on the neck orelectrodes 7L and 7R over the general area of the diaphragm. Whenelectrical stimulation is supplied through the chest electrodes, theelectrical stimulation may be provided in single amplitude pulse trainscontaining numerous pulses of 0.03 msec pulse width, delivered at 60pulses per second, delivered at amplitude up to one amp. Preferably, alinearly ramped pulse train with an initial amplitude of about 10-50milli-amps and a final amplitude of about 100-200 milli-amps, with pulsewidths of 0.01 to 0.1 msec, and 60 pulses per second, with pulse trainof 0.5 to 2 seconds. A frequency modulated pulse train may also be used,with a pulse train of about 1 second, individual pulses of 0.01 msec to0.1 msec, an amplitude of 50-200 milli-amps, with the pulse frequencyincreasing from 10 pulses per second to 100 pulses per second during thepulse train. These pulse patterns will provide for smooth inhalation andminimal potential for interference with the proper electrical operationof the heart.

For stimulation of the abdominal muscles, electrical stimulation signalsare transmitted through the abdominal electrodes 12 i and 12 s. For thecontraction of these muscles, stimulus pulse trains at about 50 Hz, 0.03msec to 0.2 msec pulse width, and up to 150 volts. The pulse patternsused here may correspond to those used for functional electricalstimulation-induced coughs for paralyzed patients.

A basic system for chest compression is shown in FIG. 3. Various modulesof the motor control system shown in FIG. 3 are the startup andpre-initiation module 20, which operates to monitor the system to detectwhen a user desires to use the system (sensed, for example, by removalof the device from a storage/charging unit), to initiate or startup thecomputer controller, to initiate communications with a remote operationcenter upon initiation of the system, the control unit will monitorinstallation of the belt via appropriate sensors in the buckles orthrough other sensors. When the motor control module 21 receives theinitiate compression signal from the control unit, the motor is started.The motor in this example is run continuously, and engaged to the beltthrough a clutch mechanism which is controlled by the control system torepeatedly engage the belt in a take up mechanism and release the belttake up mechanism to cause the desired chest compressions. This cyclicengagement of the clutch continues repeatedly for five cycles, asrecommended by current CPR guidelines, and then is interrupted for arespiration pause, if desired. A feedback module 22 monitors systemparameters or patient biophysical parameters used by the system tocontrol its operation. For example, to avoid excessive drain on thebatteries, the motor controller includes a torque sensor (sensingcurrent supply to the motor, for example) and a belt length sensor, andmonitors the torque or load on the motor. A threshold for chestcompression is established above which further compression is notdesired or useful, and if this occurs during the nominal period ofclutch engagement, then the clutch is disengaged and the cyclecontinues. The system also monitors biophysical parameters such as Bloodpressure, pulse, blood oxygen levels, EKG signals, end-tidal CO2, etc.and if found insufficient the system may adjust the maximum allowedcompression, the pace of compression, or other parameters. The cycletime and period, number of cycles between respiration pauses, and thecompression limit, can be set according to current guidelines, and canalso be varied by the remote medical personnel via the remote controlcapabilities of the control unit. As indicated, after a predeterminednumber of cycles N (usually five compressions), the system will pausefor a few seconds to allow for effective ventilation, which may beaccomplished with a bag mask, mouth-to-mouth, or through theelectroventilation described in this patent.

To provide for electro-stimulus including electro-counterpulsion,electroventilation, or synchronized cardioverting shock in the system,the system must be enabled to do so. By “enabled,” we mean that thesystem must be told that it is permitted to initiate electro-stimulusbefore it does so. The system may be provided as a dumb automatedsystem, a controlled system, or a smart automated system, depending onthe type of electro-stimulus, and the prevailing medical preferences.

For control of counterpulsion electro-stimulus in a dumb automatedsystem, the counterpulsion electro-stimulus may be enabled at all times,while in a controlled automated system, the counterpulsionelectro-stimulus will be enabled when the by-stander operator providesinput to the system, or when the remote expert medical staff remotelyenables it. In a smart automated system, the counterpulsionelectro-stimulus will be enabled when the system senses a biologicalparameter for which counterpulsion is medically indicated andautomatically stopped when the sensed biological parameter indicatesthat counterpulsion electro-stimulus is no longer indicated. While thecondition for which counterpulsion is medically indicated will vary asthe ACLS is modified over time as we gain clinical experience whichindicates the optimal conditions for counterpulsion and potential riskconditions (during which counterpulsion is counterindicated), wecurrently consider all cardiac arrest conditions to be a condition whichis an indication for counterpulsion. This condition may be sensed withEKG sensors, blood pressure sensors and pulse amplitude sensors, andfeedback from these sensors may be provided to the control system forconsideration by the system.

For control of electro-ventilation in a dumb automated system, theelectro-ventilation stimulus may be enabled at all times, while in acontrolled automated system, the electro-ventilation will be enabledwhen the by-stander operator provides input to the system, or when theremote expert medical staff remotely enables it. In a smart automatedsystem, the electro-ventilation stimulus will be enabled when the systemsenses a biological parameter for which electro-ventilation is medicallyindicated and automatically stopped when the sensed biological parameterindicates that electro-ventilation stimulus is no longer indicated.While the condition for which electro-ventilation is medically indicatedwill vary as the ACLS is modified over time and as we gain clinicalexperience which indicates the optimal conditions forelectro-ventilation and potential risk conditions (during whichelectro-ventilation is counterindicated), we currently considerrespiratory arrest to be a condition for which electro-ventilation isindicated. This condition may be sensed with CO2 sensors, air flowsensors, air temperature sensors, and chest mounted impedance sensors,and feedback from these sensors may be provided to the control systemfor consideration by the system.

Control of cardioverting shock in a dumb automated system may seemundesirable in field applications, but may prove quite useful inhospital and emergency room settings. Thus, a dumb automatic system inwhich the cardioverting shock stimulus may be enabled at all times maybe operated. Cardioverting shock is more likely to be successful whenapplied to a compressed heart, as is known by surgeons who practice openheart surgery. To take advantage of this fact, the device may beprovided in an embodiment in which it compresses the chest and appliescardioverting shock near the end of the compression period. Thisembodiment initiates a compression cycle when instructed to do so by theoperator, and automatically applies the cardioverting shock to thepatient at the optimum time near the end of the compression cycle.Additionally, because cardioverting shock is more likely to succeed whenapplied after a period of CPR, the automatic embodiment can optionallyperform CPR (and electroventilation) for a number of compression cycles,after which it automatically applies the cardioverting shock to thepatient. In a dumb automated system, the cardioverting shock is appliedautomatically after the compression strokes, without regard to furtheroperator input (except for shutdown), and without regard to biologicalparameters. After the cardioverting shock is applied, the operators canreassess the patient to determine if the heart has been successfullydefibrillated, and apply additionally cardioverting shocks according toaccepted protocols such as the ACLS.

The system can be programmed to apply cardioverting shock while in acontrolled automated mode. The cardioverting shock will be enabled whenthe by-stander operator provides input to the system, or when the remoteexpert medical staff remotely enables it. The system can be programmedto apply cardioverting shock while in a smart automated mode. In a smartautomated system, the cardioverting shock will be enabled when thesystem senses a biological parameter for which cardioverting shock ismedically indicated and automatically stopped when the sensed biologicalparameter indicates that cardioverting shock stimulus is no longerindicated. It is clearly not desired under current ACLS guidelines toperiodically defibrillate a cardiac arrest patient, so the smartautomatic system will preferably use EKG signal input to determine whendefibrillation is required, and when it has been successful orunsuccessful. The system is programmed to perform CPR, simultaneouslyassess the need for defibrillation, apply the cardioverting shock,assess the success of the cardioverting shock in defibrillating thepatient, and follow up with additional application of CPR ifdefibrillation has been unsuccessful or terminate CPR if defibrillationhas been successful in restoring normal heart rhythm and blood flow. Thesystem can continue to monitor the patient EKG'S, blood pressure andpulse in case of a recurrence of the fibrillation, a non-perfusingrhythm or a cessation of blood flow, in which case it is programmed tore-initiate CPR. While the condition for which cardioverting shock ismedically indicated will vary as the ACLS is modified over time as wegain clinical experience which indicates the optimal conditions forcardioverting shock and potential risk conditions (during whichcardioverting shock is counterindicated), we currently considerventricular fibrillation and ventricular tachycardia to be a conditionswhich are indications for cardioverting shock. These conditions may besensed with the chest mounted EKG electrodes and acoustic sensors, andfeedback from these sensors may be provided to the control system forconsideration by the system. Commercially available sensors, electrodesand EKG analysis systems such as the ForeRunner™ AED sold by HPHeartstream can be used as the basis for the cardioverting subsystem.

FIG. 4 is a block diagram of the system software in the form of a flowchart, illustrating the programming of the system which enables it toaccomplish CPR with integrated electro-counterpulsion,electroventilation and defibrillation. The pre-initiation module 30operates to monitor the system to detect when a user desires to use thesystem (again, by sensing removal of the device from a storage/chargingunit), to initiate or startup the computer controller, to initiatecommunications with a remote operation center. Additional features suchas authorizing access to pre-trained bystanders, automatically alertingemergency medical personnel to the event, and establishing enablementlimits may be performed. For instance, it may be advisable to permitelectroventilation and electro-counterpulsion to be performedautomatically by the system when accessed by moderately trainedbystanders, and permit automatic defibrillation only when the system isaccessed by highly trained bystanders, emergency medical technicians,nurses or doctors. In the system initialization module 31, the systemsoftware directs the system to check physiological feedback, initializethe control parameters, ensure that the motor is off, the clutch is offand the system counter, if the system is fitted with a counter, is setat zero for the number of compressions and number of cardiovertingshocks. The slack take-up module 32 directs the system to spool the beltto a point where it is not slack around the patient, and record systemparameters such as belt deployment length and initialize encoders usedto track the amount of chest compression provided. The compressionmodule 33 controls the system to repeatedly compress the chest with themechanisms of the chest compressing mechanism, which in our system aredescribed in detail in our co-pending U.S. patent application Ser. No.09/087,299 (now U.S. Pat. No. 6,066,106) and application Ser. No.08/922,723 (now U.S. Pat. No. 6,142,962). The “hold at compression”module 34 controls the system to maintain a period of static compressionafter each compression, if desired.

To provide for counterpulsion in this exemplary system, the system isdesigned to transmit a stimulating pulse to the intercostal nervesinnervating the abdominal muscles when the compression stroke iscomplete. Thus, each time the clutch disengages, the system checks tosee if counterpulsion is enabled and, if so, it initiates acounterpulsion stimulus, as indicated by the electro-counterpulsionmodule 35 placement after each compression and/or static compressionperiod. Thus, after each hold period, which signifies the end of thecompression stroke and the end of each hold period, the system instructsthe electro-stimulation system to stimulate the abdominal muscles tocause the counterpulsion that results from contraction of the abdominalmuscles. The counterpulsion may be initiated immediately following thecompression stroke, shortly before the end of the compression cycle, orshortly after the end of the compression cycles, or at any time betweencompression cycles. Clutch disengagement is used as the proxy for theend of the compression period in this system, but any other systemparameter may be used as a proxy for the end of the compression period.For example, motor status, brake status, pneumatic valve status (forpneumatic systems), drive piston status (for Thumper® type devices), orother actual parameters may be used. The system controller is programmedto activate the counterpulsion electro-stimulus in tandem with the proxyaction. In other words, the system, if programmed to disengage theclutch to end the compression period, initiates clutch disengagement andinitiates the counterpulsion electro-stimulation at or about the sametime. (If desired, the actual status of the proxy action may bemonitored by the system, and the actual status used by the system as thesignal to initiate the counterpulsion electro-stimulus. The actualstatus may also be checked by the system and used as a double-check onthe system status before initiation of the counterpulsionelectro-stimulus, and in this manner the possibility that counterpulsionwill be initiated during a sub-optimal portion of the chestcompression/relaxation cycles is reduced.)

It may be advantageous to stimulate the abdominal muscles intocontraction at varying points in the compression cycle. Abdominalbinding may be affected by applying the electro-stimulus pulse to theabdominal muscles near the beginning of the chest compression. If thisis desired, the electro-counterpulsion module may be reconfigured to actas an abdominal binding module, and it may be referred to at the startof the compression module operation, and the required electro-stimuluscan be applied while the compressive force is being applied to thechest.

To provide for electroventilation in this exemplary system, the systemis designed to transmit a stimulating pulse to the phrenic nerve whenthe compression stroke is complete. Thus, each time the system counts anumber of compressions desired between respiration pauses, the systeminitiates an electroventilation stimulus, as indicated by theelectroventilation module 36 placement after every group of Ncompressions and during each respiration pause. Thus, during eachrespiration pause, the system checks to determine if electroventilationis enabled, and if so, it instructs the electroventilation system tostimulate the phrenic nerve or the phrenicoabdominal branches (nervesdirectly innervating the diaphragm) to cause the electroventilation thatresults from contraction of the diaphragm muscles. The intercostalnerves may also be stimulated to activate the intercostal muscles.

The block diagram for automatic defibrillation is also illustrated inFIG. 4. The system incorporates an automatic external defibrillatorwhich is tied into the operation of the chest compression device. Thedefibrillation module 37 may incorporate any available automaticdefibrillation algorithm to determine if the EKG signals sensed by theEKG electrodes constitute a shockable rhythm (a rhythm indicating that adefibrillating shock can be expected to result in cardioversion andreturn of normal sinus rhythm to the heart). The defibrillation moduleis referred to at or near the end of each active compression stroke ifdefibrillation has been enabled. Defibrillation may be enabled in allcases, in situations where a highly trained bystander has accessed thesystem, or where the system has established communication with a remotemedical center which, through the communication system, has enabled thedefibrillation system. The system may place limits on when thedefibrillation module can be enabled, such as requiring a period of oneto two minutes of chest compression prior to allowing application ofdefibrillation of shock. The defibrillation module is referred to nearthe end of an active compression, so that the defibrillation shock canbe delivered while the heart is in a relative state of compression. Thedefibrillation module accepts feedback from installed EKG sensingelectrodes and blood pressure sensors, and may adjust the defibrillationpower according to current ACLS protocols. If the defibrillation systemdetects normal or effective EKG signals and effective blood pressure orpulse, it may then communicate to the control system or refer the systemto the emergency stop module. As shown in module 37, the decision loop37 a will maintain the system in a holding status by referring thesystem back to the EKG/blood pulse monitoring sub-module continuouslyuntil the sensed signals indicate that spontaneous blood flow hasfailed. Failure may be indicated either by absence of proper EKGsignals, indicating a non-perfusing heart rhythm, or by absence of bloodpulse or blood pressure in the presence of otherwise perfusing rhythm.Thus the system is capable of detecting the condition ofelectromechanical disassociation, in which the electrical activity ofthe heart appears normal but proper mechanical pumping action has notbeen restored, and the system can continue compression after detectingthis situation. (Although there appears to be little danger incompressing the chest of a revived or healthy patient, preservation ofsystem power, patient comfort, and bystander notification will beenhanced by preventing the system from compressing/electro-stimulating arevived patient.)

The block diagram for cardiac pacing is also illustrated in FIG. 4. Thesystem used for delivery of defibrillation stimulus may be used also forcardiac pacing, and is also tied into the operation of the chestcompression device. The pacing module 38 may incorporate any availablepacing algorithm to determine if the EKG signals sensed by the EKGelectrodes indicate the need for pacing. Currently, bradycardia (anexcessively slow heart beat) is considered the primary indication forpacing. The pacing module is referred to in the pre-initiation stagebecause it is expected that bradycardia can be treated with pacingalone, and delay of compression saves battery power in the event thatthe patient's condition degrades to the point where compression isrequired. The pacing module periodically refers to the EKG monitoringsystem to determine the continuing need for pacing, or the need to moveonto the device control module for compression and otherelectro-stimulus. (The pacing module may also be programmed to operatein tandem with the compression cycles of the chest compression device,in which case it is referred to at or near the end of each activecompression stroke, so that the pacing shock can be delivered while theheart is in a relative state of compression.)

Pacing may be enabled in all cases, in situations where a highly trainedbystander has accessed the system, or where the system has establishedcommunication with a remote medical center which, through thecommunication system, has enabled the pacing system. The system mayplace limits on when the pacing module can be enabled, such as requiringa period of one to two minutes of chest compression prior to allowingapplication of pacing of shock. The pacing module accepts feedback frominstalled EKG sensing electrodes and blood pressure sensors, and mayadjust the pacing power or timing within the compression cycles.

The block diagram for automatic glottic stimulation is also illustratedin FIG. 4. The system incorporates an automatic external recurrentlaryngeal nerve stimulator which is tied into the operation of the chestcompression device. The glottic pacing module 39 may be referred to ator near the beginning of each active compression stroke to close theglottic opening. The system checks to determine if the glottic openingcontrol has been enabled, and, if so, initiates the delivery ofelectrical stimulation at the closing frequency. Thus, just before eachcompression period (depending on medical indications at the time ofuse), the system instructs the electro-stimulation system to stimulatethe recurrent laryngeal nerve to cause the glottis to close. Thestimulus is removed after each compression, as illustrated in thissystem. However, the stimulus may be applied for the duration of the Ncompressions between respiration pauses if medically indicated.

Throughout the block diagram of FIG. 4, the system checks for input of astop signal. A stop signal may be communicated from a control panel bythe bystander operating the device, or by remote medical personnel, orby automatic operation of the system. Each subroutine and active moduleof the device (that is, modules which can instruct and operate thesystem to apply mechanical or electrical power to the patient) isprovided with an emergency stop feature wherein each active module isprogrammed to check for a stop signal prior to applying mechanical orelectrical power to the patient. Each active module may also rely on itsreferring module for checking the stop signal. For example, thecompression module 33 initiates its first compression relying upon thestop signal check performed in the slack take-up module 32 prior toreference from the slack take-up module 32 to the compression module.Thereafter, the compression module relies upon emergency stop check 40within the compression module.

Upon sensing an emergency stop signal, the system refers to theemergency stop module 41. The emergency stop module then operates thesystem to put it into a safe condition. This includes operating themechanical system to release compression of the body by turning off thesystem or controlling operation of the system to pay out the compressionbelt so that it exerts little or no force on the body, then disablingfurther compression. It also includes disabling or turning off theelectroventilation, electro-counterpulsion, and defibrillation modulesso that they will not apply electrical stimulation to the body. The shutdown preferably maintains sensing, communications, display and systeminitiation modules in operation so that the bystanders may determine thestatus of the patient, and possibly re-initiate compression if needed.

Several of the control system modules depend on sensed electricalsignals from the patient or from the compression device. However, thepower required for defibrillation, electro-stimulus of the respiratorysystem, and pacing represent electrical surges of significant powerrelative to the sensing systems. For this reason, the feedback devicesused to provide information to the system should be protected withcircuitry which isolates the necessary signal processing systems fromelectrical signals with voltage or current far in excess of the expectedfeedback signals.

The term electro-stimulation system may refer to a system thatstimulates the vagal nerve at any point, the phrenic nerve at any point,the abdominal muscle nerves, or the heart from any point on or withinthe body. The electrical pulse generator may provide a pulse intended tostimulate a nerve which controls a muscle or muscle group (as with thephrenic nerves) or it may be intended to affect the electrical activityof the heart (as with a pacing stimulus or a cardioverting shock). Thechest compression device used may be the circumferential belt and thedrive system illustrated in our patents, such as U.S. Pat. No.6,066,106, or our co-pending patent applications, such as applicationSer. No. 09/345,645 (now U.S. Pat. No. 6,398,745) and Ser. No.09/866,377 (now U.S. Pat. No. 6,616,620), or the compression device maybe a pneumatic bladder, a reciprocating piston or other system. In thiscase, the block diagram of FIG. 4 can readily be adapted to controlthose mechanisms, and the complimentary electro-stimulation modules canbe controlled in coordination with the particular mechanical systemused.

It is not necessary that the chest compression device actually exert aforce on the chest to expand the chest. It is sufficient for the deviceto cause expansion of the chest by releasing the compression forceexerted on the chest during the compression portion of the cycle,thereby permitting the natural elasticity of the thoracic cavity to leadto chest expansion. However, systems providing activecompression/decompression, which actually exert a force on the chest toexpand the chest (usually a suction force) may also be incorporated intothe system.

Thus, while the preferred embodiments of the devices and methods havebeen described in reference to the environment in which they weredeveloped, they are merely illustrative of the principles of theinventions. Other embodiments and configurations may be devised withoutdeparting from the spirit of the inventions and the scope of theappended claims.

1. A device for compressing the chest of a patient comprising: a chestcompression device capable of repeatedly compressing the chest of thepatient and causing or allowing the chest to expand; anelectro-stimulation system comprising an electrode attached to the bodyand an electrical stimulation generator operably connected to theelectrode, said electrical stimulation generator being capable ofgenerating electrical energy and transmitting said energy to theelectrode; a controller for controlling the chest compression device andthe electro-stimulation system, said controller programmed to coordinatethe operation of the chest compression device with the operation of theelectro-stimulation system so that the electro-stimulation systemtransmits electrical energy to the electrode after CPR is performed fora number of compression cycles during periods of time when the chestcompression device is causing or allowing the chest to compress for aperiod of static compression.
 2. A device for compressing the chest of apatient comprising: a chest compression device capable of repeatedlycompressing the chest of the patient and causing or allowing the chestto expand, thereby establishing a cycle of compressive periods andexpansive periods in the net forces applied to the chest; anelectro-stimulation system comprising an electrode attached to the bodyand an electrical stimulation generator operably connected to theelectrode, said electrical stimulation generator being capable ofgenerating electrical energy and transmitting said energy to theelectrode; a controller for controlling the chest compression device andthe electro-stimulation system, said controller programmed to coordinatethe operation of the chest compression device with the operation of theelectro-stimulation system so that the electro-stimulation systemtransmits electrical energy to the electrode during the period of timespanning the end of at least one of the compressive periods and thebeginning of the next proceeding expansive period.
 3. A device forresuscitating a patient comprising: a chest compression device capableof compressing the chest of the patient and causing or allowing thechest to expand, thereby establishing at least one compressive periodand at least one expansive period in the net forces applied to thechest; an electro-stimulation system comprising an electrode attached tothe body and an electrical stimulation generator operably connected tothe electrode, said electrical stimulation generator being capable ofgenerating electrical energy and transmitting said energy to theelectrode; a controller for controlling the chest compression device andthe electro-stimulation system, said controller programmed to coordinatethe operation of the chest compression device with the operation of theelectro-stimulation system so that the electro-stimulation systemtransmits electrical stimulation to the electrode during the staticperiod of compression spanning the end of said at least one compressiveperiod and the beginning of said at least one expansive period.
 4. Adevice for resuscitating a patient having a chest comprising:compressing means for repeatedly compressing the chest of the patient;defibrillating means for applying the defibrillating stimulus to thepatient; sensing means for assessing the need for defibrillation of thepatient and the success of defibrillating stimulus in defibrillating thepatient; control means for controlling the operation of the compressingmeans, the sensing means, and the defibrillating means said controlmeans to assess the need for defibrillation, perform CPR for apredetermined number of compression cycles and apply a defibrillatingstimulus to the patient after the predetermined number of compressioncycles when the patient's chest is compressed and continue repeatedlycompressing the chest if defibrillation has been unsuccessful or stopcompressing the patient if defibrillation has been successful.
 5. Adevice for resuscitating a patient having a chest comprising:compressing means for repeatedly compressing the chest; defibrillatingmeans for applying the defibrillating stimulus to the patient; sensingmeans for determining if the patient exhibits a non-perfusing rhythm,electro-mechanical disassociation, or normal cardiac function; controlmeans for controlling the operation of the compressing means and thedefibrillation means in response to the sensing means, said controlmeans being capable of causing the compressing means to compress thepatient when the sensing means determines that the patient exhibits anon-perfusing rhythm or electro-mechanical disassociation, said controlmeans being capable of causing the defibrillating means to apply adefibrillating stimulus to the patient when the sensing means determinesthat the patient exhibits a non-perfusing rhythm, and said control meansbeing capable of causing the defibrillation means to apply thedefibrillating stimulus to the patient when the chest is compressed. 6.The device of claim 5 wherein the sensing means further comprises: meansfor sensing the electrical activity of the patient's heart anddetermining if the heart electrical activity proceeds in a perfusingrhythm, means for sensing the flow of blood within the patient todetermine if the heart operates in the perfusing rhythm, and means forcomparing the sensed electrical activity with the sensed blood flow todetermine if the heart is effectively pumping blood; and the controlmeans is further capable of causing the compressing means to compressthe patient when the electrical activity of the patient's heartindicates appropriate perfusing rhythm but the sensed blood flowindicates that the heart is not operating in perfusing rhythm, and saidcontrol means being further capable of causing the defibrillating meansto apply a defibrillating stimulus to the patient when the electricalactivity of the patient's heart indicates a non-perfusing rhythm.
 7. Thedevice of claim 1, further comprising at least one feedback deviceoperably connected to the patient, wherein said feedback devicecomprises a sensor, an electrical signal generator and a signaltransmitter, and said feedback device senses at least one biologicalparameter of the patient, generates a corresponding electrical signal,and transmits the corresponding signal to the controller, and whereinthe controller is programmed to adjust the operation of theelectro-stimulation system on the basis of the sensed feedback.
 8. Thedevice of claim 7, wherein said feedback device comprises a protectioncircuit for protecting the feedback device from the electrical energyapplied by the electro-stimulation system.
 9. The device of claim 2,further comprising at least one feedback device operably connected tothe patient, wherein said device comprises a sensor, an electricalsignal generator and a signal transmitter, and said feedback devicesenses at least one biological parameter of the patient, generates acorresponding electrical signal, and transmits the corresponding signalto the controller, and wherein the controller is programmed to adjustthe operation of the electro-stimulation system on the basis of thesensed feedback.
 10. The device of claim 9, wherein said feedback devicecomprises a protection circuit for protecting the feedback device fromthe electrical energy applied by the electro-stimulation system.
 11. Thedevice of claim 2, further comprising at least one feedback deviceoperably connected to the patient, wherein said device comprises asensor, an electrical signal generator and a signal transmitter, andsaid feedback device senses at least one biological parameter of thepatient, generates a corresponding electrical signal, and transmits thecorresponding signal to the controller, and wherein the controller isprogrammed to adjust the operation of the electro-stimulation system onthe basis of the sensed feedback.
 12. The device of claim 11, whereinsaid feedback device comprises a protection circuit for protecting thefeedback device from the electrical energy applied by theelectro-stimulation system.
 13. The device of claim 1, wherein thecontroller is capable of receiving a stop signal input signifying acommand to cease chest compression and electro-stimulation, and saidcontroller is programmed to check for a stop signal before each cycle ofchest compression and before each transmission of electrical energy tothe electrode.
 14. The device of claim 2, wherein the controller iscapable of receiving a stop signal input signifying a command to ceasechest compression and electro-stimulation, and said controller isprogrammed to check for a stop signal before each cycle of chestcompression and before each transmission of electrical energy to theelectrode.
 15. The device of claim 3, wherein the controller is capableof receiving a stop signal input signifying a command to cease chestcompression and electro-stimulation, and said controller is programmedto check for a stop signal before each cycle of chest compression andbefore each transmission of electrical energy to the electrode.
 16. Thedevice of claim 4, wherein the controller is capable of receiving a stopsignal input signifying a command to cease chest compression anddefibrillation, and said controller is programmed to check for a stopsignal before each cycle of chest compression and before eachapplication of a defibrillating stimulus to the patient.
 17. The deviceof claim 5, wherein the controller is capable of receiving a stop signalinput signifying a command to cease chest compression anddefibrillation, and said controller is programmed to check for a stopsignal before each cycle of chest compression and before eachapplication of a defibrillating stimulus to the patient.
 18. The deviceof claim 6, wherein the controller is capable of receiving a stop signalinput signifying a command to cease chest compression anddefibrillation, and said controller is programmed to check for a stopsignal before each cycle of chest compression and before eachapplication of a defibrillating stimulus to the patient.